Tech Compliance Analyst II

Job Summary

Tech Compliance Analyst II

Responsibilities

• Manage and/or coordinate the writing and execution of validation protocols, specifications, change controls and/or scripts related to software, instruments and/or equipment according to the organizations compliance requirements and industry regulations.
• Provide support for Information Technology s project portfolio within assigned projects, ensuring that technology solutions are classified in accordance with set standards, implemented to support those standards within agreed upon timelines.
• Coordinate assigned project deliverables with external consultants and suppliers concerning the implementation, validation, support and maintenance to ensure these activities are completed in alignment with standard compliance principles.
• Serve as subject matter expert in specialized project area to support client and regulatory agency audits and inspections for Information Technology activities.
• Lead compliance efforts for any corrective or preventative actions plans supporting assigned Information Technology solutions.
• Execute harmonization of compliance activities to support mergers, acquisitions and internal expansion of the compliance program.
• Act as a compliance resource expert to other groups.
• Assist internal clients with requests and problem resolution, participate in the maintenance of documentation and make recommendations for greater effectiveness in functional area of compliance
• Make recommendations for continued improvement in the area of compliance for Information Technology.
• Perform training in the principles of computerized systems validation for internal personnel.
• Conduct periodic reviews of validation documentation to ensure systems continue to operate in a validated state, and perform impact assessments on planned GxP and Business Critical Change Management requests.
• Perform quality reviews of validation deliverables.

Qualifications

What we're looking for

• 4+ Yrs of Experience, with Bachelors Degree in Computer Science or related science field or equivalent.
• Experience with 21 CFR Part 11 required
• Experience in computer systems validation/software development life cycle approaches.
• Experience in working in a clinical trials environment, including a comprehensive knowledge of GCP regulations guidelines
• Effective verbal and written communication

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